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# OTC Monograph Submission Format Guidance
- URL: https://www.fdaweb.com/otc-monograph-submission-format-guidance/
- Published: 2022-09-27T12:00:00.000Z
- Updated: 2026-09-14T18:00:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152819

FDA has published a draft guidance, *Providing Over-the-Counter Monograph Submissions in Electronic Format*, to assist submitters by describing the electronic over-the-counter electronic submission requirement in section 505G(j) of the Federal Food, Drug, and Cosmetic Act, which was added by the Coronavirus Aid, Relief, and Economic Security Act of 2020\. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-over-counter-monograph-submissions-electronic-format?ref=fdaweb.com) has recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format, as required by the act.